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検索対象: 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格
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1. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

262 ISO 9000 NOTE 2 A set of documents, for example speci- fications and records, is frequently called "docu- mentatlon ” . NOTE 3 Some requirements ( 3.1.2 ) (). g. the requirement t0 be readable) relate tO all types 0f documents, however there can be different reqmre- ments for specifications (). g. the requmement t0 be revislon controlled) and records (). g. the reqmre- ment tO be retrievable). 3.7.3 specification document ( 3.7.2 ) stating requirements ( 3.1.2 ) NOTE A specification can be related to activities (). g. procedure document, process specification and test specification), or products ( 3.4.2 ) (). g. product specification, performance specification and drawing). 3.7.4 quality manual

2. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

42 ISO 9001 Where exclusions are made, claims of conformity t0 this lnternational Standard are not acceptable unless these exclusions are limited tO reqture- ments within Clause 7 , and such exclusions do not affect the organization's ability, or responsibility, tO provlde product that meets customer and appli- cable statutory and regulatory requlrements. 2 Normative references The following reference d documents are indi s - pensable for the application Of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applie s. ISO 9000 : 2005 , Q リ 0 〃 ma age 襯 e れ systems リれ dame 厩 als 0 れ d u0C06 リ厄 3 Terms and definitions For the purposes of this document, the terms and

3. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

264 ISO 9000 document ( 3.7.2 ) specifymg the quality man- agement system ( 3.2.3 ) Of an organization ( 3.3.1 ) NOTE Quality manuals can vary ⅲ detail and format t0 suit the size and complexity of an indi- Vidual organization. 3.7.5 quality plan document ( 3.7.2 ) specifying which procedures ( 3.4.5 ) and associated resources shall be applied by whom and when to a specific proj ect ( 3.4.3 ) , product ( 3.4.2 ) , process ( 3.4.1 ) or contract NOTE 1 These procedures generally include those referring t0 quality management processes and tO product realization processes. NOTE 2 A quality plan often makes reference to parts 0f the quality manual ( 3.7.4 ) or t0 proce- dure documents. NOTE 3 A quality plan is generally one of the results of quality planning ( 3.2.9 ).

4. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

50 ISO 9001 The quality management system documentation shall include d) documented statements Of a quality policy and quality objectives, a quality manual, documented procedures and records required by this lnternational Standard, and documents, including records, determined by the organization tO be necessary t0 ensure the effective planning, operation and control of its processes. NOTE 1 Where the term "documented proce- dure" appears within this lnternational Standard this means that the procedure is established, doc- umented, implemented and maintained. A single document may address the requn•ements for one or more procedures. 、 A. reqmrement for a docu- mented procedure may be covered by more than one document. NOTE 2 The extent of the quality management system documentation can differ from one orgam- zation to another due to a) the size of organization and type of activities,

5. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

52 ISO 9001 b) the complexity Of processes and their interac- tions, and c) the competence of personnel. NOTE 3 The documentation can be ⅲ any form or type 0f medium. 4.2.2 QuaIity manual The organization shall establish and maintain a quality manual that includes a) b) c) the scope 0f the quality management system, including details 0f and justification for any exclusions (see 1.2 ) , the documented procedures established for the quality management system, or reference to them, and a description 0f the interaction between the processes Of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according t0 the reqturements given in 4.2.4.

6. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

242 3.4.5 procedure ISO 9000 specified way t0 carry out an activlty or a process ( 3.4.1 ) NOTE 1 NOTE 2 Procedures documented not. When a procedure is documented, the term "written procedure" or "documented proce- dure ” is frequently used. The document ( 3.7.2 ) that contains a procedure can be called a proce- dure document ” 3.5 Terms relating to characteristics

7. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

206 ISO 9000 NOTE 1 "Generally implied ” means that it is custom or common practice for the organization ( 3.3.1 ) , its customers ( 3.3.5 ) and other interest- ed parties ( 3.3. の , that the need or expectation under consideration iS implied. NOTE 2 A qualifier can be used to denote a specific type 0f requlrement, e. g. product requlre- ment, quality management requlrement, custom- er reqtllrement. NOTE 3 A specified requirement is one that is stated, for example ⅲ a document ( 3.7.2 ). NOTE 4 Requirements can be generated by dif- ferent interested parties ( 3.3.7 ). NOTE 5 This definition differs from that provid- ed ⅲ 3.12.1 ofISO/IEC Directives, Part 2 : 2004. 3.12.1 requirement expresslon in the content Of a document con- veymg criteria to be fulfilled if compliance with the document is to be claimed and from

8. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

54 ISO 9001 A documented procedure shall be established to define the controls needed d) f) g) t0 approve documents for adequacy prior t0 lssue, tO revlew and update as necessary and re-ap- prove documents, t0 ensure that changes and the current revi- SIOn status Of documents are identified, t0 ensure that relevant verslons 0f applicable documents are available at points of use, tO ensure that documents remain leglble and readily identifiable, tO ensure that documents 0f external origln determined by the organization to be neces- sary for the planning and operation 0f the quality management system are identified and their distribution controlled, and tO prevent the unintended use Of obsolete doc- uments, and t0 apply suitable identification t0 them if they are retained for any purpose. 4.2.4 ControI of records Records established to provide evidence of confor-

9. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

266 3.7.6 record ISO 9000 document ( 3.7.2 ) stating results achieved or pro- V1ding evidence 0f activities performed NOTE 1 Records can be used, for example, to document traceability ( 3.5.4 ) and to provide evi- dence 0f verification ( 3.8.4 ) , preventive action ( 3.6.4 ) and corrective action ( 3.6.5 ). NOTE 2 Generally records need not be under reVIS10n control. 3.8 Terms relating to examination 3.8.1 objective evidence data supporting the existence or verity of some- thin g NOTE Objective evidence may be obtained through observation, measurement, test ( 3.8.3 ) , or other means.

10. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

260 3.6.13 release ISO 9000 pernussion t0 proceed t0 the next stage 0f a pro- cess ( 3.4.1 ) NOTE ln English, ⅲ the context of computer software, the term "release" is frequently used tO refer to a verslon of the software itself. 3.7 Terms relating to documentation 3.7.1 information meaningful data 3.7.2 document information ( 3.7.1 ) and its supporting medium EXAMPLE Record ( 3.7.6 ) , specification ( 3.7.3 ) , procedure document, drawing, report, standard. NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.